Lawsuit Challenges Medically Unjustified FDA Restrictions that Push Medication Abortion Out of Reach

October 3, 2017

KAUAI, Hawaii — The American Civil Liberties Union today filed suit on behalf of a Hawaii doctor and several professional health care associations to challenge federal restrictions that significantly limit access to medication abortion.

The federal lawsuit filed in the U.S. District Court for the District of Hawaii challenges FDA restrictions (known as a Risk Evaluation and Mitigation Strategy or REMS) on where a woman may receive the abortion pill Mifeprex, a safe and effective method of ending an early pregnancy up to 10 weeks. Currently, a patient may not fill a prescription for this medication at a retail pharmacy, which delays and in some cases blocks entirely a woman’s access to abortion.

A REMS is a set of restrictions that the FDA may impose only when necessary to ensure that a drug’s benefits outweigh its risks. This lawsuit argues that the FDA’s burdensome restrictions on medication abortion fail that test. The FDA mandates that, rather than fill a prescription for Mifeprex at a retail pharmacy, the patient must be handed the medication at a clinic, medical office, or hospital from a health care provider who has pre-registered with the drug manufacturer and arranged to order and stock the abortion pill in their health care facility.

Because of these added administrative hurdles or opposition to abortion within their health care facilities, many clinicians across the country are unable to satisfy these medically unnecessary requirements — leaving some patients with no option but to seek an abortion elsewhere, if they can obtain this care at all. For many patients, arranging and paying for an additional trip to a second health care provider who has pre-registered and arranged to stock this medication can be challenging or insurmountable.

“The abortion pill is safe, effective, and legal. So why is the FDA keeping it locked away from women who need it?” said Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project. “The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

While the FDA restrictions affect women from every walk of life, women in the most rural and medically underserved areas of the country — such as the island of Kauai, where there are currently no abortion providers — experience some of the greatest harm. Although plaintiff Dr. Graham Chelius, a family medicine doctor on Kauai, is qualified and willing to provide medication abortion, he cannot stock the abortion pill at the hospital where he works. As a result, his patients must make a 300-mile round trip flight to another island to get abortion care. This requirement delays a woman’s abortion — sometimes by weeks — while she arranges and pays for transport, time off work, and childcare. This delay pushes some women past the point at which they can use this early medication method; others cannot access abortion care at all.

“I believe it’s my moral obligation to provide my patients with the care they need—whether that’s maternity care or abortion,” said Dr. Chelius. “Unfortunately, because of the FDA’s restrictions, my patients are forced either to fly to a different provider on another island — resulting in serious delays — or to carry a pregnancy to term against their will.”

The abortion pill is a medically-proven medication that 3 million women in the U.S. have used to end an early pregnancy (up to 10 weeks) in the privacy of their own homes and on their own terms. Leading medical associations — including the American College of Obstetricians and Gynecologists — support ending the REMS and making the abortion pill available at the pharmacy by prescription.

“Overwhelming medical evidence and decades of clinical experience show medication abortion to be a safe and effective method to end a pregnancy,” said Dr. Paul Blumenthal, director of the Gynecology Service at Stanford University. “There is simply no medical justification for these restrictions, and they create a needless and harmful burden for women seeking this care.”

Indeed, as the FDA itself acknowledged in 2016, Mifeprex “has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.”

“Many people think it’s easy to get an abortion in the U.S., but it’s not. Some women, especially in rural areas, have trouble getting the care they need,” noted Mateo Caballero, legal director of the ACLU of Hawaii. “The abortion pill is a safe, proven method to end a pregnancy — but politically-motivated regulations place needless burdens on women seeking this option.”

This lawsuit comes more than a year after the landmark Supreme Court decision in Whole Woman’s Health v. Hellerstedt, which emphasized that health regulations must actually serve patient health and cannot burden access to abortion without a valid medical justification.

Plaintiffs include Dr. Chelius, the Society of Family Planning, California Academy of Family Physicians, and Pharmacists Planning Services Inc. They are represented by attorneys with the ACLU and the ACLU of Hawaii.

More about this case can be found here: https://www.aclu.org/cases/chelius-v-wright​ ​​​​​​

The complaint can be found here: https://www.aclu.org/legal-document/chelius-v-wright-complaint

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